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Intensive Medicines Monitoring Study of Toripalimab Monoclonal Injection (Tuoyi) .

NCT04234620 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2020-01-21

No results posted yet for this study

Summary

This study was a prospective, single-arm, multi-channel, multicenter, non-interventional real-world study to evaluate the safety and efficacy of Toripalimab injection in the treatment of unresectable or metastatic melanoma with previously systemic failure . The study population currently included only in the melanoma cohort-unresectable or metastatic melanoma patients who had previously failed systemic therapy. If new indications are approved during the implementation of the project, patients with new indications using Toripalimab injection will also be included in this study as a new cohort.This study uses offline (physical hospital) and online (DTP pharmacy and Lingke (Yinchuan) Internet hospital) to collect data and information, relying on Lingke technology (Beijing) Co., Ltd. EDC (Medical Research Cloud) database for data collection and processing. The classification of adverse events was based on the general toxicity evaluation standard NCI CTCAE 5.0 of the National Institute of Oncology (Chinese version).

Conditions

Interventions

DRUG

Toripalimab injection

240 mg/6 mL/vial. The recommended dose of Toripalima is 3 mg/kg, intravenous infusion every 2 weeks until disease progression or intolerable toxicity.

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2023-02-01
Completion
2023-07-05

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234620 on ClinicalTrials.gov